Status:
COMPLETED
Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Meningococcal
Eligibility:
All Genders
10-18 years
Phase:
PHASE2
Brief Summary
The main purposes for conducting the study are firstly to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 ye...
Eligibility Criteria
Inclusion
- Adolecents from 10-18 yearsof age, generally in good health, and available for all study visits, and who/whose legally acceptable representative has given written informed consent at the time of enrollment.
- Individuals of who the investigator believes can and will comply with the requirements of the protocol (e.g. use of an eDiary, return for follow-up visits, available for phone contacts).
- Female subjects of childbearing potential must have a negative urine preganancy test.
Exclusion
- Serious, acute, or chronic illness. Previous or suspected disease caused by N. meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines.
- Exposure to individuals with clicically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characteriszation.
Key Trial Info
Start Date :
August 21 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2016
Estimated Enrollment :
1063 Patients enrolled
Trial Details
Trial ID
NCT02212457
Start Date
August 21 2014
End Date
March 3 2016
Last Update
June 27 2019
Active Locations (32)
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1
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
2
GSK Investigational Site
Hialeah, Florida, United States, 33012
3
GSK Investigational Site
Melbourne, Florida, United States, 32934
4
GSK Investigational Site
Augusta, Kansas, United States, 67010